If you have a kidney disorder, stomach ulcers, or if your body does not absorb minerals easily, your doctor should be notified in advance before you start using this bisphosphonate before you buy Boniva. Boniva Dosage Doctors usually recommend taking a single tablet of Boniva mg every month or can prescribe a daily dose of Boniva 2.
If you are taking one tablet a month, then take it on the same date every month. If you are using Boniva daily, then take this tablet on an empty stomach first thing in the morning with a tall glass of water. Do not take this medication with milk or any other liquid. You should not eat anything for up to one hour after using Boniva. Swallow the whole tablet and do not crush it or break it to avoid irritation in esophagus.
In case of a drug overdose, consult your physician immediately. Your doctors may recommend you Vitamin D and calcium supplements when you buy Boniva. Interactions Inform the doctor about all the prescription, non-prescription and over the counter medications that you are using before they recommend that you take Boniva.
Consider a dental examination with appropriate preventive dentistry prior to treatment with bisphosphonates in patients with a history of concomitant risk factors e. While on treatment, patients with concomitant risk factors should avoid invasive dental procedures if possible.
For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. The time to onset of symptoms varied from one day to several months after starting the drug.
Most patients had relief of symptoms after stopping the bisphosphonate. A subset of patients had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Atypical Subtrochanteric and Diaphyseal Femoral Fractures Atypical , low-energy, or low- trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients.
These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.
Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates. Atypical femur fractures most commonly occur with minimal or no trauma to the affected area.
They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids e. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. The relevance of these findings to humans is unknown.
Exposure multiples comparing human and rodent doses were calculated using human exposure at the recommended intravenous dose of 3 mg every 3 months, based on cumulative AUC comparison.
Mutagenesis There was no evidence for a mutagenic or clastogenic potential of ibandronate in the following assays: Ibandronate was not genotoxic in the in vivo mouse micronucleus tests for chromosomal damage. Impairment of Fertility In female rats treated from 14 days prior to mating through gestation, decreases in fertility, corpora lutea and implantation sites, and increased preimplantation loss were observed at an intravenous dose of 1. In male rats treated for 28 days prior to mating, a decrease in sperm production and altered sperm morphology were observed at intravenous doses greater than or equal to 0.
Exposure multiples comparing human and rat doses were calculated using human exposure at the recommended intravenous dose of 3 mg every 3 months, based on cumulative AUC comparison. Animal Pharmacology Animal studies have shown that ibandronate is an inhibitor of osteoclast-mediated bone resorption. In the Schenk assay in growing rats, ibandronate inhibited bone resorption and increased bone volume, based on histologic examination of the tibial metaphyses.
This indicates that Boniva Injection administered at a therapeutic dose is unlikely to induce osteomalacia. Long-term daily or intermittent administration of ibandronate to ovariectomized rats or monkeys was associated with suppression of bone turnover and increases in bone mass. Ibandronate maintained the positive correlation between bone mass and strength at the ulna and femoral neck.
New bone formed in the presence of ibandronate had normal histologic structure and did not show mineralization defects. Clinical Studies Treatment of Postmenopausal Osteoporosis Quarterly Intravenous Injection The effectiveness and safety of Boniva Injection 3 mg once every 3 months were demonstrated in a randomized, double-blind, multinational, noninferiority study in women with postmenopausal osteoporosis L2-L4 lumbar spine BMD, T-score below The control group received Boniva 2.
The primary efficacy parameter was the relative change from baseline to 1 year of treatment in lumbar spine BMD, which was compared between the intravenous injection and the daily oral treatment groups.
All patients received international units vitamin D and mg calcium supplementation per day. The mean difference between groups was 1. The mean increase from baseline in total hip BMD at 1 year was 2. Consistently higher BMD increases at the femoral neck and trochanter were also observed following Boniva Injection 3 mg once every 3 months compared to Boniva 2. Daily Oral Tablets The effectiveness and safety of Boniva daily oral tablets were demonstrated in a randomized, double-blind, placebo-controlled, multinational study Treatment Study of women aged 55 to 80 years, who were on average 21 years postmenopause, who had a lumbar spine BMD 2 to 5 SD below the premenopausal mean T-score in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Boniva was evaluated at oral doses of 2. The main outcome measure was the occurrence of new radiographically diagnosed, vertebral fractures after 3 years of treatment. The diagnosis of an incident vertebral fracture was based on both qualitative diagnosis by the radiologist and quantitative morphometric criterion.
The morphometric criterion required the dual occurrence of two events: The generic name of the drug is Ibandronate, and it belongs to the class of drugs known as bisphosphonates. Boniva works by altering the formation and bone teardown process of the patient. In this way, bone density or bone mass is increased, and the loss of bones is prevented.
Other than post-menopausal women, Boniva can also be used for preventing osteoporosis in cancer patients whose disease has spread to their bones. Side Effects for Boniva Injection Back pain, diarrhea, headache, swelling or redness in the eyes, nausea, an upset stomach, or pain in the legs or arms are the common side effects of Boniva Injection.
Some patients may also experience local site reactions such as swelling or redness at the site of the injection. Most of these side effects are temporary and subside within a few days. However, if any of these become intolerable, you should contact your doctor and seek medical help. Some serious but rare side effects of Boniva Injection include pain during, or difficulty swallowing, chest pain, severe bone, muscle, or joint pain, jaw pain, heartburn, burning or pain under the ribs, or unusual pain in the hip or thigh.
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